The present invention is directed to a method for cannulating a biliary duct as part of a laparoscopic cholangiographic surgical procedure, and to a guide instrument therefor for presenting a catheter or the like to the biliary duct at a select confrontation angle.
Cholecystectomy or gallbladder removal has been carried out in a structured surgical manner since about 1882. The heretofore conventional approach to the procedure has involved the surgical opening of the body cavity, typically via a right quadrant incision, and direct hand access to the organ on the part of the surgeon aided by three-dimensional vision and touch. This surgical procedure continued for over 100 years until the 1980s when a new treatment employing laparoscopy somewhat abruptly supplanted the earlier orthodox procedure. The appeal of this new treatment modality resides in the less invasive character of the procedure, which is carried out with correspondingly less pain, incision, and scar, shorter term hospitalization, and improved cost considerations.
In general, the laparoscopic approach to cholecystectomy commences with the insufflation of the peritoneal cavity of the anesthetized patient. Typically, this expansion of the cavity (pneumoperitoneum) is carried out by the controlled insertion of an insufflating agent such as carbon dioxide through a supraumbilically inserted Verres needle. That needle is operatively associated with an insufflator machine, usually providing a pressure and flow rate control over the insufflating agent. A sequence of cannulas are placed into the peritoneal cavity using sharp, removable inserts called trocars. These cannulas are valved devices through which a video imaging camera and light source along with various thin, elongate instruments can be passed and manipulated from outside of the patient's body during the procedure. Cannulas vary in port diameter, ranging, for instance, from 5 mm to 18 mm. Generally, the first cannula is installed adjacent the umbilicus and serves to initially receive a laparoscope or video camera and light source. It is the video output of this device as observed by the surgeon at a video monitor which provides all of the visual perceptive data for hand maneuvering the elongate laparoscopic instruments. As the video camera is guided by a surgical assistant, these instruments, having a necessary length of about 18 inches (45.72 cm), are held at one end by the surgeon who, while viewing the video monitor, carries out refined and delicate dissecting, isolating and clamping maneuvers within the moving, dynamic environment of the peritoneal cavity.
The gallbladder is the reservoir for bile which, with the hepatic, cystic, and common bile ducts, forms the excretory apparatus of the liver. Conical or pear shaped in gross anatomy, the gallbladder exists as a musculo-membranous sac lodged in a fossa on the undersurface of the right lobe of the liver, and extends from near the right extremity of the transverse fissure to the anterior border of the organ. It is about 4 inches (10.16 cm) in length, 1 inch (2.54 cm) in breadth at its widest part, and holds from eight to ten drachms. The organ is divided into a fundus, body, and neck or infundibulum. The fundus or broad extremity is directed downward, forward and to the right, and projects beyond the anterior border of the liver. The body and neck are directed upward and backward to the left. The vascular system of the gallbladder is derived from branches of the hepatic artery.
The upper surface of the gallbladder is attached to the liver by connective, i.e., areolar, tissue and vessels. The under surface is covered by peritoneum, which is reflected on to it from the surface of the liver. Occasionally, the whole of the organ is invested by the serosa membrane, and is then connected to the liver by a kind of mesentery. Adipose tissue often invests the gallbladder and its biliary and vascular anatomy.
In wall structure, the gallbladder consists of three coats, namely, serous, fibrous and muscular, and mucous. The external or serous coat is derived from the peritoneum and completely invests the fundus, but covers the body and neck only on their under surface. The fibro-muscular coat is a thin but strong layer which forms the framework of the sac and consists of dense, fibrous tissue which interlaces in all directions. The internal or mucous coat is loosely connected with the fibrous layer and is covered with columnar epithelium. The mucous membrane secretes an abundance of thick, viscid mucus.
As aforementioned, both the gallbladder and liver are associated with a biliary anatomy including three biliary ducts: the cystic duct, the common bile-duct (ductus communis choledochus), and the hepatic duct. The cystic duct, typically exhibiting a very small diameter of about 1/8 inch (3.175 mm) joins the hepatic duct to form a common bile duct which extends to an orifice upon the summit of the papilla situated at the inner side of the descending portion of the duodenum. The external coat of the cystic duct is fibrous and composed of strong fibro-areolar tissue with a certain amount of muscular tissue arranged in a circular manner around the duct.
As gall stones may be present in the common bile duct, under earlier, open surgical cholecystectomy procedures, the surgeon has been able to palpate the common bile duct and visualize its diameter for determining whether a cholangiogram would be necessary to detect any occult stones. This procedure was essentially straightforward utilizing the surgeon's stereoscopic direct vision and tactile senses at the fingertips. However, in laparoscopic surgery, the common bile duct is not tactilely accessible by the surgeon, but is viewed two-dimensionally and remotely on a television monitor, making it difficult for the surgeon to appreciate turns in the ductal structures. Thus, and as retained stones in the biliary anatomy present the possibility for injuries to the major ductal structures during laparoscopic cholecystectomy, a cholecystcholangiographic protocol is generally indicated for management of ductal stones. Indeed, cholangiography is useful both for demonstrating the cystic duct/common hepatic duct junction to delineate abnormal anatomy, and for indicating the presence of any stones in the common bile duct.
One technique for cholecystcholangiography involves retracting the gallbladder laterally and elevating it up to the abdominal wall. Upon being brought into apposition with the abdominal wall, the gallbladder is then punctured percutaneously with a needle to aspirate bile and to effect a decompression. A syringe of contrast material such as a barium fluid or the like then is attached to the needle for refilling the gallbladder with an amount of the contrast material equal in volume to the amount of bile which was aspirated. At this point, the gallbladder is viewed radiographically with a fluoroscope or the like to assess the biliary anatomy and to determine whether stones are present within the common bile duct.
Although the above-described cholangiographic technique is relatively easily effected given the constraints of two-dimensional remote vision and diminished tactile data, the injection of contrast fluid directly into the sac of the gallbladder sac engenders a risk of flushing any stones contained therein into the ductal system where removal is made more difficult. Accordingly, a cystic duct cholangiography protocol is often specified. In this protocol, the gallbladder is grasped with atraumatic grasping forceps at the fundus and, optionally, at the infundibulum to place the cystic duct in tension. Any adhesions between the gallbladder and the adjacent organs, e.g., omentum, right colon flexure and duodenum, may be bluntly divided or transected with a hooked electrode or scissors. With the gallbladder separated and adequate traction maintained, the cystic duct is dissected from its areolar and/or adipose investment using forceps, hook electrodes, or scissors. In this regard, it is generally preferred that dissection is begun at the infundibulum and proceeds in the direction of the common bile duct to expose junction of the cystic and hepatic ducts.
Upon adequate exposure of the duct, the upper neck of the gallbladder is then closed by peripherally clipping the cystic duct near its junction with the infundibulum of the gallbladder. With the gallbladder grasped near the infundibulum to stretch the cystic duct, an instrument such as a pair of laparoscopic microscissors is used to partially transect the cystic duct on the common bile duct side of the previously placed clip. Following the partial transection of the cystic duct, a cholangiography catheter is percutaneously inserted at an angle to orient the catheter towards the opening in the duct. The catheter is selected as being flexible and having outer diameter suited for insertion into the duct. The tip of the catheter is guided into the cystic duct through the opening, and is secured in the duct by clipping. It generally is preferred that saline is injected through the catheter during clipping to assure its potency. Once the catheter is secured within the cystic duct, cholangiography is performed in a routine fashion.
After satisfactory cholangiograms have been obtained, the cholecystectomy procedure continues with the retrieval of any ductal stones and, thereafter, with the division of the cystic duct. With respect to the division of the cystic duct, the duct first is clipped centrally near its junction with the common bile duct. The duct then is divided between the central clip and the peripheral clip previously placed near the infundibulum of the gallbladder. As the duct is divided, traction is maintained on the neck of the gallbladder away from the liver to more clearly expose the cystic artery.
With the cystic duct divided, the cystic artery next may be addressed. Indeed, it is preferred to first divide the cystic duct before the cystic artery is dissected as closure and division of the cystic duct as a first step permits a better identification and a safer closure of the cystic artery. As with the cystic duct, the cystic artery, for its identification, also may have to be dissected free of an areolar and/or adipose investment, again with the use of forceps, hook electrodes, or scissors. Division of the artery then may proceed via a double clip ligation and a transection with scissors between the clips.
Following the division of the cystic duct and arteries, the intraoperative procedure continues with the dissection of the gallbladder from the liver. Generally, this dissection proceeds by alternately retracting the gallbladder medially and laterally with concurrent elevation to place the interposing tissue under tension. With the interposing tissue placed in tension, it may be separated either bluntly with dissecting forceps, sharply with scissors, or with a monopolar electrosurgical instrument or a bipolar forceps. The gallbladder then may be removed from the body through a lateral trocar. For further information concerning laparoscopy and its use in conjunction with cholecystectomy, reference is made to the following publications, the disclosures of which are expressly incorporated herein by reference:
Saleh, J. W., "Laparoscopy," W. D. Saunders Co., 1988.
Graber, J. N., Schultz, L. S., Pietrafitta, J. J., and Hickok, D. F., "Laparoscopic Abdominal Surgery," McGraw-Hill, Inc., 1993.
Hunter, J. G., and Sackier, J. M., "Minimally Invasive Surgery," McGraw-Hill, Inc., 1993.
Cuschieri, A., Buess, G., and Pe/ rissat, J., "Operative Manual of Endoscopic Surgery," Springer-Verlag, 1992.
As aforementioned, a cholangiogram protocol generally is indicated in laparoscopic cholecystectomy procedures to assist both in the detection of bile duct stones and in the visualization of ductal abnormalities and the like. Indeed, the above-described cystic duct cholangiography protocol often is specified in cholecystcholangiography to minimize the risk of stone migration from the gallbladder sac into the ductal system. However, there has been reported a 23.3% failure rate, defined as the inability to cannulate or inject the cystic duct, for attempted laparoscopic cholangiography. "The Southern Surgeons Club: A Prospective Analysis of 1518 Laparoscopic Cholecystectomies," New England Journal of Medicine, 324:1073-1078, 1991. Kumar has observed that this relatively high failure rate for attempted laparoscopic cholangiography provides one explanation for the sporadic use of cholangiograms in laparoscopic cholecystectomies despite the demonstrated advantages thereof. Kumar, S. S., "Laparoscopic Cholangiography: A New Method and Device," Journal of Laparoendoscopic Surgery, 2(5):247-254, 1992.
Kumar additionally has observed that reasons for the high failure rate may be attributed to the narrow, tortuous structure of the cystic duct anatomy which can defy cannulation, and to the fact that the cannulating devices heretofore known in the art may confront a difficult cannulation angle which complicates the insertion of the catheter into the duct. Although such devices, as described in Smith III, U.S. Pat. No. 4,817,604, Lazarus et al., U.S. Pat. No. 4,792,339, Uddo, Jr., U.S. Pat. No. 4,735,615, and Berlin et al., U.S. Pat. No. 4,484,911, for open surgery cholangiography, and in Noda, U.S. Pat. No. 5,071,412, for laparoscopic cholangiography, have been proposed to facilitate cholangiographic procedures, the failure rate for intraoperative cystic duct cholangiograms, and especially for laparoscopic cholangiograms, nevertheless has remained unacceptable. Because of the continuing difficulties encountered in performing cystic duct laparoscopic cholangiography, Kumar has proposed an alternative method wherein the infundibulum, i.e., ampulla or Hartmann's pouch, is cannulated instead of the cystic duct. Such method, as is described in Kumar, U.S. Pat. No. 5,224,931, entails the use of a clamp having a 5 mm grasper with atraumatic jaws and a side channel for introduction of a cholangiocatheter formed as having a 22-gauge needle terminating one end of a clear, polymeric catheter. After completion of routine peritoneoscopy and cephalad retraction of the gallbladder fundus by a grasper inserted through the right lateral subcoastal port, the clamp is introduced into the peritoneal cavity through the right mid-subcoastal port. The clamp then is applied across the lower part of the body of the gallbladder just above the infundibulum. The jaws of the clamp are provided to extend across the gallbladder for its division into two separate sections, namely, an anterior compartment and a posterior or medial compartment which includes mainly the bulging pouch of the infundibulum. The infundibulum is punctured at a 15.degree. angle with the needle of the catheter which has been inserted through the side channel of the clamp. Approximately 5 to 15 ml of dye then is injected through the catheter under C-arm fluoroscopy or the like. Upon completion of the cholangiography, the catheter is removed, and the proximal port of the side channel is occluded with a rubber cap to avoid loss of the pneumoperitoneum. The clamp then may be used as a regular grasper for the completion of the operation.
Although success rates of over 80% have been reported with the Kumar clamp, commentators have noted several disadvantages with the clamp and its method of use. Principally, these disadvantages stem from a perception that the clamp and its methodology are inapplicable when the gallbladder exhibits a cholecystitis pathology, and that the cholangiogram obtained is less desirable than a true cystic duct cholangiogram. "New Laparoscopic Clamp Eases Intraoperative Cholangiography," General Surgery & Laparoscopy News, pp. 1-19, September (1993). Accordingly, there has existed and remains a need for laparoscopic instruments and techniques which facilitate the obtaining of the cystic duct cholangiograms which are considered preferred. It is apparent that such instruments and techniques would be well-received by practitioners and would represent an important improvement in laparoscopic surgery.